Empirical Therapy Versus Tailored Therapy of Helicobacter pylori in Korea: Results of the K-CREATE Study

IF 4.3 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Helicobacter Pub Date : 2024-08-15 DOI:10.1111/hel.13126

Joon Sung Kim, Byung-Wook Kim, Jin Il Kim, Woo Chul Chung, Sung Woo Jung, Chang Seok Bang, Gwang Ha Kim, Seon Woo Jeon, Moon Kyoung Joo, Si Hyung Lee, Yun Jeong Lim, Jae Kyu Sung, Seung Young Seo, Sun Young Park, Wan Sik Lee, Hang Lak Lee, Ki Bae Kim, Heung Up Kim

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Abstract

Background

The optimal duration of regimens for tailored therapy based on genotypic resistance for clarithromycin has yet to be established.

Aim

This study was a nationwide, multicenter, randomized trial comparing empirical therapy with tailored therapy based on genotypic resistance for first-line eradication of Helicobacter pylori. We also compared the eradication rates of 7- and 14-day regimens for each group.

Patients and Methods

Patients with H. pylori infection were first randomized to receive empirical or tailored therapy. Patients in each group were further randomized into 7- or 14-day regimens. Empirical therapy consisted of a triple therapy (TT) regimen (twice-daily doses of pantoprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg) for 7 or 14 days. Tailored therapy consisted of TT of 7 or 14 days in patients without genotypic resistance. Patients with genotypic resistance were treated with bismuth quadruple therapy (BQT) regimens (twice-daily doses of pantoprazole 40 mg, three daily doses of metronidazole 500 mg, and four times daily doses of bismuth 300 mg and tetracycline 500 mg) for 7 or 14 days. A ¹³C-urea breath test assessed eradication rates. The primary outcome was eradication rates of each group.

Results

A total of 593 patients were included in the study. The eradication rates were 65.7% (201/306) in the empirical therapy group and 81.9% (235/287) in the tailored therapy group for intention-to-treat analysis (p < 0.001). In the per-protocol analysis, the eradication rates of the empirical therapy and tailored groups were 70.3% (201/286) and 85.5% (235/274) (p < 0.001), respectively. There was no difference in compliance between the two groups. The rate of adverse events was higher in the tailored group compared to the empirical group (p < 0.001).

Discussion

Our study confirmed that tailored therapy based on genotypic resistance was more effective than empirical therapy for H. pylori eradication in Korea. However, no significant difference was found between 7- and 14-day regimens for each group. Future studies are needed to determine the optimal duration of therapy for empirical and tailored therapy regimens.

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韩国幽门螺旋杆菌的经验疗法与定制疗法：K-CREATE研究的结果。

背景：基于克拉霉素基因型耐药性的定制疗法的最佳疗程尚未确定：目的：本研究是一项全国范围内的多中心随机试验，比较了经验疗法和基于基因型耐药性的定制疗法在一线根除幽门螺旋杆菌方面的效果。我们还比较了每组 7 天和 14 天疗法的根除率：幽门螺杆菌感染患者首先被随机分为经验疗法组和定制疗法组。每组患者再随机分为 7 天或 14 天治疗方案。经验疗法包括为期 7 天或 14 天的三联疗法（TT）方案（泮托拉唑 40 毫克、阿莫西林 1 克和克拉霉素 500 毫克，每日两次）。对于无基因型耐药性的患者，定制疗法包括 7 天或 14 天的 TT。基因型耐药患者接受铋剂四联疗法（BQT）治疗（每日两次泮托拉唑 40 毫克、每日三次甲硝唑 500 毫克、每日四次铋剂 300 毫克和四环素 500 毫克），疗程为 7 或 14 天。13C-尿素呼气试验评估根除率。主要结果是各组的根除率：结果：共有 593 名患者参与了研究。在意向治疗分析中，经验疗法组的根除率为 65.7%（201/306），而定制疗法组的根除率为 81.9%（235/287）（P 讨论：我们的研究证实了以 13C 尿素呼气试验为基础的定制疗法是有效的：我们的研究证实，在韩国，基于基因型耐药性的定制疗法比经验疗法对根除幽门螺杆菌更有效。然而，7 天和 14 天治疗方案在各组之间没有发现明显差异。今后的研究需要确定经验疗法和定制疗法的最佳疗程。

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来源期刊

Helicobacter 医学-微生物学

CiteScore

8.40

自引率

9.10%

发文量

审稿时长

2 months

期刊介绍： Helicobacter is edited by Professor David Y Graham. The editorial and peer review process is an independent process. Whenever there is a conflict of interest, the editor and editorial board will declare their interests and affiliations. Helicobacter recognises the critical role that has been established for Helicobacter pylori in peptic ulcer, gastric adenocarcinoma, and primary gastric lymphoma. As new helicobacter species are now regularly being discovered, Helicobacter covers the entire range of helicobacter research, increasing communication among the fields of gastroenterology; microbiology; vaccine development; laboratory animal science.